hireejobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Global Regulatory Submission Publishing Associate

3.00 to 5.00 Years   Hyderabad   01 Nov, 2019
Novartis Healthcare Pvt Ltd
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Your responsibilities: Your responsibilities include, but are not limited to:

  • Responsible for electronically preparing, publishing, quality reviews, validation (using eCTD validator tool), and dispatch activities related to regulatory submissions (e.g., INDs, BLAs/NDAs, MAAs, HA AtoQs, Global Labeling, Annual Reports, etc.).
  • Produce high quality, HA compliant submission outputs in varying formats (eCTD, NeeS, and Paper) in adherence to assigned timelines and compliance with worldwide HA requirements (US, EU, LACan, Most of World).
  • Partners with Operations Submission Managers and a publishing team located in 3 regions (e.g., US, EU, and India) and actively functions in a global capacity.
  • Liaises /collaborates with cross-functional team members and document authors (e.g., Project Management, Clinical, Nonclinical, CMC, Safety and Quality functions) to achieve timely dispatch of high-quality submissions.
  • Comply with and actively apply internal work practices and guidelines. Support the implementation of new technologies, tools, and processes as well as contribute to ongoing initiatives and training efforts.
  • Identify the process or technical issues and propose solutions relating to timing, quality, compliance, and resources.
  • Contributes to process efficiencies, process documentation and knowledge transfer efforts within the RA team

Minimum requirements

What you ll bring to the role:

  • Bachelors in life sciences or a relevant discipline with a minimum 3- 5 years of submission publishing experience in Pharma or related industry.
  • Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
  • Effective interpersonal skills, strong written and oral communication and presentation skills in English
  • Project management and time management skills to manage multiple ongoing projects simultaneously.
  • Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
  • Working knowledge of regulatory affairs.
  • Works independently and with minimal supervision.
  • Proficiency in computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly.
  • Analytical skills and problem-solving skills.
  • Ability to coordinate and work effectively with cross-functional teams
,

Keyskills :
ms officelife sciences annual reportsproblem solving time managementquality reviews work effectivelyanalytical skills

APPLY NOW

Global Regulatory Submission Publishing Associate Related Jobs

© 2019 Hireejobs All Rights Reserved